US11813410B2 - Controllable expandable catheter - Google Patents

Controllable expandable catheter Download PDF

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Publication number
US11813410B2
US11813410B2 US16/767,081 US201816767081A US11813410B2 US 11813410 B2 US11813410 B2 US 11813410B2 US 201816767081 A US201816767081 A US 201816767081A US 11813410 B2 US11813410 B2 US 11813410B2
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Prior art keywords
control member
deflection control
medical device
spline
elongate medical
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US16/767,081
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US20200375657A1 (en
Inventor
Gregory K. Olson
Rishi Manda
Travis Dahlen
Troy T. Tegg
Brian M. Monahan
Russell D Terwey
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St Jude Medical Cardiology Division Inc
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St Jude Medical Cardiology Division Inc
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Assigned to ST JUDE MEDICAL CARDIOLOGY DIVISION, INC reassignment ST JUDE MEDICAL CARDIOLOGY DIVISION, INC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: MONAHAN, Brian M., DAHLEN, Travis, OLSON, GREGORY K, TEGG, TROY T, MANDA, Rishi, Terwey, Russell D
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Definitions

  • This disclosure relates to systems and apparatuses for catheter-based cardiac electrophysiology mapping andtherapy.
  • the instant disclosure relates to controllable expandable basket catheters for mapping and therapy.
  • Electrophysiology catheters are used in a variety of diagnostic and/or therapeutic medical procedures to correct conditions such as atrial arrhythmia, including for example, ectopic atrial tachycardia, atrial fibrillation, and atrial flutter.
  • Arrhythmia can create a variety of dangerous conditions including irregular heart rates, loss of synchronous atrioventricular contractions and stasis of blood flow which can lead to a variety of ailments and even death.
  • a catheter is manipulated through a patient's vasculature to, for example, a patient's heart, and carries one or more electrodes which may be used for mapping, ablation, diagnosis, or other therapies and/or treatments.
  • treatment may include radio frequency (RF) ablation, cryoablation, lasers, chemicals, high-intensity focused ultrasound, etc.
  • RF radio frequency
  • An ablation catheter imparts such ablative energy to cardiac tissue to create a lesion in the cardiac tissue. This lesion disrupts undesirable electrical pathways and thereby limits or prevents stray electrical signals that lead to arrhythmias.
  • RF radio frequency
  • some type of navigation may be used, such as using mechanical steering features incorporated into the catheter (or an introducer).
  • medical personnel may manually manipulate and/or operate the catheter using the mechanical steering features.
  • a navigating system may be used.
  • Such navigating systems may include, for example, electric-field-based positioning and navigating systems that are able to determine the position and orientation of the catheter (and similar devices) within the body and map features of the body.
  • Various therapies can be delivered by the catheter to tissue with varied shapes and sizes.
  • tissue configurations and to provide sufficient contact with the tissue for therapy, it can be important to have multiple sensors coupled with flexible spline elements on structures such as distal basket configurations to map the tissue and/or to contact the tissue for therapy.
  • the ability to vary the stiffness of the flexible spline elements can allow for more useful configurations of the baskets or other flexible structures (e.g., more contact with tissue for treatment, etc.).
  • the instant disclosure in at least one embodiment, comprises an expandable structure with an expandable configuration and a collapsed configuration, a handle, operably coupled to the expandable structure; the handle further including a selective movement limiter, and a deflection control member coupled with the distal hub, where the deflection control member is configured to adjust a stiffness of the expandable structure, from a first stiffness to a second stiffness, and maintain the first stiffness or the second stiffness when the selective movement limiter couples with the deflection control member and limits a longitudinal movement of the deflection control member, wherein the deflection control member is configured to move freely when the selective movement limiter is not coupled with the deflection control member.
  • a method of using a catheter with an expandable structure can comprise placing the catheter with the expandable structure in an undeployed shape in a body, where the expandable structure comprises a plurality of splines; deploying the expandable structure from the undeployed shape to a deployed shape, where the expandable structure has a first stiffness; and adjusting the stiffness of the expandable structure, using a deflection control member, from the first stiffness to a second stiffness.
  • a system comprising: a basket, where the basket comprises a plurality of splines where each has a spline proximal end and a spline distal end; a distal hub, where each of the spline distal ends is coupled with the distal hub; a magnetic sensor; a deflection control member coupled with the distal hub, where the deflection control member is configured to adjust a stiffness of the basket, from a first stiffness to a second stiffness, and maintain the first stiffness or the second stiffness; a clamping mechanism where the clamping mechanism engages the deflection control member and limits a longitudinal movement of the deflection control member
  • FIG. 1 is a system diagram showing a medical device and a medical positioning system, in accordance with embodiments of the present disclosure.
  • FIG. 2 is a diagrammatic view of a catheter system that is designed to perform one or more diagnostic and/or therapeutic functions, in accordance with embodiments of the present disclosure.
  • FIG. 3 A is an isometric view of a distal end portion of a catheter with a basket including a plurality of ring electrodes, in accordance with embodiments of the present disclosure.
  • FIG. 3 B is an isometric view of a catheter including a basket comprising multiple splines where one or more of the splines includes one or more electrodes located at a proximal portion of the respective spline, in accordance with embodiments of the present disclosure.
  • FIG. 4 is a side view of a distal portion of a catheter including a basket comprising multiple splines including two magnetic sensors positioned in a distal location of the basket, in accordance with embodiments of the present disclosure.
  • FIG. 5 A is a side view of a distal end portion of a distal portion of a catheter including a basket comprising a plurality of splines including two magnetic sensors positioned at a proximal location of the basket, in accordance with embodiments of the present disclosure.
  • FIG. 5 B is a side view of the distal end portion of the catheter of FIG. 4 A including the two magnetic sensors positioned at the proximal location of the basket, in accordance with embodiments of the present disclosure.
  • FIGS. 6 A-C show a coupler, in accordance with embodiments of the present disclosure.
  • FIG. 6 A is a cross-sectional view of a proximal end of the coupler.
  • FIG. 6 B is a side view of the coupler.
  • FIG. 6 C is a cross-sectional view of the distal end of the coupler.
  • FIG. 7 is cross-sectional view of a catheter including a plurality of lumens for use with a catheter, in accordance with embodiments of the present disclosure.
  • FIG. 8 A is a side view of a distal end portion of a catheter including a basket comprising multiple splines and a deflection control member with the basket in a first configuration, in accordance with embodiments of the present disclosure.
  • FIG. 8 B is a side view of the catheter of FIG. 6 A in a second configuration, in accordance with embodiments of the present disclosure.
  • FIG. 8 C is a side view of the catheter of FIG. 6 A in a third configuration, in accordance with embodiments of the present disclosure.
  • FIG. 9 A is a partial cross-sectional view of a distal end portion of a catheter with a basket and a deflection control member, in accordance with embodiments of the present disclosure.
  • FIG. 9 B is a side view of a distal end portion of a catheter similar to FIG. 3 including a basket comprising multiple splines and a deflection control member, in accordance with embodiments of the present disclosure.
  • FIGS. 10 A and 10 B are isometric views of a clamping mechanism for limiting and/or preventing longitudinal movement of a deflection control member, where FIG. 9 A shows the clamping mechanism in a first position and FIG. 9 B shows the clamping mechanism in a second position, in accordance with embodiments of the present disclosure.
  • FIG. 11 A is a cross-sectional view of a portion of a handle for controlling an elongated medical device including a clamping mechanism for limiting and/or preventing longitudinal movement of the elongated medical device, in accordance with embodiments of the present disclosure.
  • FIG. 11 B is an isometric view of a portion of the clamping mechanism of FIG. 10 A for preventing longitudinal movement of the elongated medical device, in accordance with embodiments of the present disclosure.
  • FIG. 11 C is an isometric view of the mechanism of FIGS. 11 A-B for preventing longitudinal movement of the elongated medical device, in accordance with embodiments of the present disclosure.
  • FIG. 12 A is a side view of two splines for a catheter where each of the two splines have a first spline shape, in accordance with embodiments of the present disclosure.
  • FIG. 12 B is a side view of two splines for a catheter with a second spline shape for increased contact between proximal portions of the splines and tissue, in accordance with embodiments of the present disclosure.
  • FIG. 1 illustrates one embodiment of a system 10 for navigating a medical device within a body 12 .
  • the medical device comprises a catheter 14 that is shown schematically entering a heart that has been exploded away from the body 12 .
  • the catheter 14 in this embodiment, is depicted as an irrigated radiofrequency (RF) ablation catheter for use in the treatment of cardiac tissue 16 in the body 12 .
  • RF radiofrequency
  • the system 10 may be used to navigate, for example, an electrophysiological catheter, a mapping catheter, an intracardiac echocardiography (ICE) catheter, or an ablation catheter using a different type of ablation energy (e.g., cryoablation, ultrasound, etc.). Further, it should be understood that the system 10 may be used to navigate medical devices used in the diagnosis or treatment of portions of the body 12 other than cardiac tissue 16 . Further description of the systems and components are contained in U.S. patent application Ser. No. 13/839,963 filed on 15 Mar. 2013, which is hereby incorporated by reference in its entirety as though fully set forth herein.
  • the ablation catheter 14 is connected to a fluid source 18 for delivering a biocompatible irrigation fluid such as saline through a pump 20 , which may comprise, for example, a fixed rate roller pump or variable volume syringe pump with a gravity feed supply from fluid source 18 as shown.
  • the catheter 14 is also electrically connected to an ablation generator 22 for delivery of RF energy.
  • the catheter 14 may include a handle 24 ; a cable connector or interface 26 at a proximal end of the handle 24 ; and a shaft 28 having a proximal end 30 , a distal end 32 , and one or more electrodes 34 .
  • the connector 26 provides mechanical, fluid, and electrical connections for conduits or cables extending from the pump 20 and the ablation generator 22 .
  • the catheter 14 may also include other conventional components not illustrated herein such as a temperature sensor, additional electrodes, and corresponding conductors or leads.
  • the handle 24 provides a location for the physician to hold the catheter 14 and may further provide means for steering or guiding the shaft 28 within the body 12 .
  • the handle 24 may include means to change the length of one or more pull wires extending through the catheter 14 from the handle 24 to the distal end 32 of shaft 28 .
  • the construction of the handle 24 may vary.
  • the shaft 28 may be made from conventional materials such as polyurethane and may define one or more lumens configured to house and/or transport electrical conductors, fluids, or surgical tools.
  • the shaft 28 may be introduced into a blood vessel or other structure within the body 12 through a conventional introducer.
  • the shaft 28 may then be steered or guided through the body 12 to a desired location such as the tissue 16 using guide wires or pull wires or other means known in the art including remote control guidance systems.
  • the shaft 28 may also permit transport, delivery, and/or removal of fluids (including irrigation fluids and bodily fluids), medicines, and/or surgical tools or instruments.
  • any number of methods can be used to introduce the shaft 28 to areas within the body 12 . This can include introducers, sheaths, guide sheaths, guide members, guide wires, or other similar devices.
  • introducer will be used throughout.
  • the system 10 may include an electric-field-based positioning system 36 , a magnetic-field-based positioning system 38 , a display 40 , and an electronic control unit (ECU) 42 (e.g., a processor).
  • ECU electronice control unit
  • the electric-field-based positioning system 36 and the magnetic-field-based positioning system 38 are provided to determine the position and orientation of the catheter 14 and similar devices within the body 12 .
  • the position and orientation of the catheter 14 and similar devices within the body 12 can be determined by the system 36 and/or the system 38 .
  • the system 36 may comprise, for example, the EnSiteTM NavXTM system sold by St. Jude Medical, Inc. of St. Paul, Minn., and described in, for example, U.S. Pat. No. 7,263,397 titled “Method and Apparatus for Catheter Navigation and Location Mapping in the Heart,” the entire disclosure of which is hereby incorporated by reference as though fully set forth herein.
  • the systems 36 and 38 may comprise, for example, the EnSite PrecisionTM system sold by St.
  • the system 36 operates based upon the principle that when low amplitude electrical signals are passed through the thorax, the body 12 acts as a voltage divider (or potentiometer or rheostat) such that the electrical potential or field strength measured at one or more electrodes 34 on the catheter 14 may be used to determine the position of the electrodes, and, therefore, of the catheter 14 , relative to a pair of external patch electrodes using Ohm's law and the relative location of a reference electrode (e.g., in the coronary sinus).
  • a voltage divider or potentiometer or rheostat
  • the electric-field-based positioning system 36 further includes three pairs of patch electrodes 44 , which are provided to generate electrical signals used in determining the position of the catheter 14 within a three-dimensional coordinate system 46 .
  • the electrodes 44 may also be used to generate EP data regarding the tissue 16 .
  • the patch electrodes are placed on opposed surfaces of the body 12 (e.g., chest and back, left and right sides of the thorax, and neck and leg) and form generally orthogonal x, y, and z axes.
  • a reference electrode/patch (not shown) is typically placed near the stomach and provides a reference value and acts as the origin of the coordinate system 46 for the navigation system.
  • the patch electrodes include right side patch 44 X1 , left side patch 44 X2 , neck patch 44 Y1 , leg patch 44 X2 , chest patch 44 Z1 , and back patch 44 Z2 ; and each patch electrode is connected to a switch 48 (e.g., a multiplex switch) and a signal generator 50 .
  • the patch electrodes 44 X1 , 44 X2 are placed along a first (x) axis; the patch electrodes 44 Y1 , 44 Y2 are placed along a second (y) axis, and the patch electrodes 44 Z1 , 44 Z2 are placed along a third (z) axis.
  • Sinusoidal currents are driven through each pair of patch electrodes, and voltage measurements for one or more position sensors (e.g., ring electrodes 34 or a tip electrode located near the distal end 32 of catheter shaft 28 ) associated with the catheter 14 are obtained.
  • the measured voltages are a function of the distance of the position sensors from the patch electrodes.
  • the measured voltages are compared to the potential at the reference electrode and a position of the position sensors within the coordinate system 46 of the navigation system is determined.
  • the magnetic-field-based positioning system 38 in this exemplary embodiment employs magnetic fields to detect the position and orientation of the catheter 14 within the body 12 .
  • the system 38 may include the GMPS system made available by MediGuide, Ltd. and generally shown and described in, for example, U.S. Pat. No. 7,386,339 titled “Medical Imaging and Navigation System,” the entire disclosure of which is hereby incorporated by reference as though fully set forth herein.
  • a magnetic field generator 52 may be employed having three orthogonally arranged coils (not shown) to create a magnetic field within the body 12 and to control the strength, orientation, and frequency of the field.
  • the magnetic field generator 52 may be located above or below the patient (e.g., under a patient table) or in another appropriate location.
  • Magnetic fields are generated by the coils and current or voltage measurements for one or more position sensors (not shown) associated with the catheter 14 are obtained.
  • the measured currents or voltages are proportional to the distance of the sensors from the coils, thereby allowing determination of a position of the sensors within a coordinate system 54 of system 38 .
  • the display 40 is provided to convey information to a physician to assist in diagnosis and treatment.
  • the display 40 may comprise one or more conventional computer monitors or other display devices.
  • the display 40 may present a graphical user interface (GUI) to the physician.
  • GUI graphical user interface
  • the GUI may include a variety of information including, for example, an image of the geometry of the tissue 16 , electrophysiology data associated with the tissue 16 , graphs illustrating voltage levels over time for various electrodes 34 , and images of the catheter 14 and other medical devices and related information indicative of the position of the catheter 14 and other devices relative to the tissue 16 .
  • the ECU 42 provides a means for controlling the operation of various components of the system 10 , including the catheter 14 , the ablation generator 22 , and magnetic generator 52 of the magnetic-field-based positioning system 38 .
  • the ECU 42 may also provide a means for determining the geometry of the tissue 16 , electrophysiology characteristics of the tissue 16 , and the position and orientation of the catheter 14 relative to tissue 16 and the body 12 .
  • the ECU 42 also provides a means for generating display signals used to control the display 40 .
  • the voltage readings from the electrodes 34 change, thereby indicating the location of catheter 14 within the electric field and within the coordinate system 46 established by the system 36 .
  • the ring electrodes 34 communicate position signals to ECU 42 through a conventional interface (not shown).
  • FIG. 2 is a diagrammatic view of a catheter system 10 A employing an expandable structure 11 in accordance with an embodiment of the present teachings.
  • Catheter system 10 A includes an actuator 13 that is part of a handle 14 A and connectors 15 disposed proximal to handle 14 A for making electrical connections to a visualization, navigation, and/or mapping system (not shown) such as those systems available under the brand name EnsiteTM NavXTM (aka EnsiteTM “Classic” as well as newer versions of the EnsiteTM system, denoted as EnsiteTM VelocityTM) and available from St. Jude Medical, Inc.
  • EnsiteTM NavXTM aka EnsiteTM “Classic” as well as newer versions of the EnsiteTM system, denoted as EnsiteTM VelocityTM
  • Handle 14 A can have a uni-directional design, a bi-directional design, or any other suitable design and be accordingly configured to steer the expandable structure 11 , as discussed in more detail in commonly assigned U.S. Pat. No. 8,676,290, the entire disclosure of which is incorporated herein by reference.
  • the actuator 13 e.g., button, lever, knob, etc.
  • the actuator 13 can be used to engage a control element for controlling features of the expandable structure 11 (e.g., size, shape, stiffness, etc.).
  • Catheter system 10 A can also include an introducer 17 located distally of handle 14 A that may be used to deliver an elongated catheter body 19 into the body of a patient, through a hemostasis valve of another longer introducer, for example.
  • Elongated catheter body 19 can extend from introducer 17 .
  • Elongated catheter body 19 can comprise an elongated tubular construction having one or more lumens.
  • Elongated catheter body 19 can be flexible or bendable.
  • Elongated catheter body 19 can be of any suitable construction and made of any suitable material as known to those of ordinary skill in the art.
  • Elongated catheter body 19 can have any outer diameter, but may generally be configured for insertion into the vasculature of a body of a patient and, in some embodiments, be less than about 8 French.
  • Elongated catheter body 19 can have an outer wall of any thickness, but may generally be configured so that one or more lumens can be disposed within elongated catheter body 19 to accommodate pull wires, lead wires, sensor cables, and any other wires, cable, and/or tubes that may be needed in particular applications.
  • Handle 14 A, connectors 15 , introducer 17 , and elongated catheter body 19 can be readily modified as dictated by the aesthetic or functional needs of particular applications.
  • Expandable structure 11 is configured to extend from a distal portion 21 of elongated catheter body 19 .
  • expandable structure 11 may be utilized in connection with other types of medical devices, such as for example and without limitation, stone retrieval baskets, distal protection devices, renal artery ablation devices, snares, and other retrieval devices.
  • expandable structure 11 may be configured to support electrodes and to be radially outwardly expandable and inwardly collapsible
  • FIG. 3 A an isometric view of a distal end portion of an elongate medical device with a basket including a plurality of ring electrodes, in accordance with embodiments of the present disclosure.
  • An elongate medical device 60 A i.e., a catheter 60 A
  • the basket 62 A can comprise a distal hub 64 A and a plurality of splines 66 A and a deflection control member 68 A.
  • Each of the plurality of splines 66 A can include a plurality of interactive elements 70 A, where 70 A x can represent individual interactive elements in the plurality of interactive elements 70 A 1 , 70 A 2 , 70 A 3 , . . . etc. as shown in the exemplary configuration of FIG. 3 A .
  • the interactive elements can include, for example, electrodes, energy delivery elements, thermocouples, force sensors (to register, for example, tissue contact and/or total force exerted on tissue), strain gauges, strain sensors, position sensors, biosensors (e.g., sensors capable of converting a biological response to an electrical signal), diagnostic sensors, therapy sensors, chemical sensors (e.g., capable of delivery and or monitoring of drugs/chemicals, etc.), light-emitting sensors, acoustic sensors, ultrasound sensors, energy receiving and/or measuring sensors, a magnetic coil or sensor, thermoelectric elements, or other sensors.
  • force sensors to register, for example, tissue contact and/or total force exerted on tissue
  • strain gauges strain sensors
  • strain sensors position sensors
  • biosensors e.g., sensors capable of converting a biological response to an electrical signal
  • diagnostic sensors e.g., diagnostic sensors, therapy sensors, chemical sensors (e.g., capable of delivery and or monitoring of drugs/chemicals, etc.)
  • light-emitting sensors e.
  • the interactive elements can be electrically connected (e.g., a plurality of conductive electrical traces, wires, etc.) to a power supply, controller (e.g., ECU 42 of FIG. 1 ), an ablation generator (e.g., the ablation generator 22 of FIG. 1 ), a positioning system 36 and/or 38 of FIG. 1 ) or other device used to, for example, delivery therapy, generate, amplify, receive, and/or process a signal.
  • controller e.g., ECU 42 of FIG. 1
  • an ablation generator e.g., the ablation generator 22 of FIG. 1
  • other device used to, for example, delivery therapy, generate, amplify, receive, and/or process a signal.
  • Spacing of the plurality of interactive elements 70 A can be equal or unequal.
  • the plurality of interactive elements 70 A can all have an equal distance between each of the plurality of interactive elements 70 A (e.g., 1 mm between each electrode).
  • the spacing can vary between the plurality of interactive elements 70 A (e.g., 1 mm between some of the plurality of electrodes 70 A and 2 mm between others of the plurality of interactive elements 70 A).
  • a typical range of spacing between each of the plurality of interactive elements 70 A can be approximately 0.5 mm to 2 mm.
  • Tighter spacing (i.e., closer interactive elements, shorter/less distances between interactive elements, etc.) of the plurality of interactive elements can be used, for example, for contact mapping compared to non-contact mapping where the interactive elements can be further apart (greater/more distance between interactive elements) compared to the contact mapping arrangement).
  • Spacing between each of the plurality of interactive elements 70 A can vary along each spline 66 A and/or differ from spline to spline.
  • one embodiment (not shown) of the plurality of interactive elements 70 A could have a first spacing pattern (A) on a first spline and a second spacing pattern (B) on a second spline with the spacing patterns alternating every other spline (A-B-A-B . . . ).
  • Another example could include a third spacing pattern (C) allowing the splines/spacing patterns to have a configuration of A-B-C-A-B-C, etc.
  • any suitable number of spacing patterns for the plurality of interactive elements 66 A is possible with any possible combination/arrangement of the splines with the different spacing patterns (e.g., A-A-A-B-B-B, etc.; A-A-B-B-C-C, etc.).
  • Distribution of the plurality of interactive elements 70 A can also vary between embodiments.
  • one embodiment can include more of the plurality of interactive elements 70 A located on the distal portion of the splines 66 A and fewer of the plurality of interactive elements 70 A on the proximal portion of the splines 66 A (e.g., FIG. 2 B ).
  • a first pattern of distribution a spline 66 A can have four interactive elements on a distal portion of the spline (i.e., distal spline interactive elements), four interactive elements on the equatorial portion (e.g., proximate a midpoint between the distal spline end and the proximal spline end) of the spline 66 A (i.e., equatorial spline interactive elements), and four interactive elements on the proximal portion of the spline 66 A (i.e., proximal spline interactive elements).
  • Another pattern of distribution could include four interactive elements 70 A on the distal and equatorial portions of the spline 66 A only. Still another pattern of distribution could be four interactive elements on the distal portion of the spline 66 A, four interactive elements on the equatorial portion, and two interactive elements on the proximal portion. Any suitable combination of different distribution patterns of interactive elements on the splines can be used to accommodate various physiological features in a body.
  • Each spline 66 A can have one or more proximal spline interactive elements (not shown in FIG. 3 A ; see, e.g., 70 prox in FIG. 3 B ) located at a proximal portion of the spline 66 A.
  • the one or more proximal spline interactive elements e.g., 70 prox can facilitate contact with tissue (e.g., heart wall such as the septum between the right atrium/left atrium at fossa crossing) proximal the proximal end portion of the basket 62 A for therapy (e.g., ablation). See FIG. 3 B below and related discussion for additional information.
  • Each of the plurality of interactive elements 70 A can be any suitable type of electrode.
  • a ring electrode e.g., as shown in FIG. 3 A
  • a printed electrode e.g., as shown in FIG. 3 B
  • the plurality of interactive elements 70 A can include a combination of electrode types (e.g., all ring electrodes, all printed electrodes, a mixture of the two, and/or other configurations/types of electrodes and/or other interactive elements).
  • Ring electrodes can go all the way around the spline 66 A (e.g., cover an entire circumference of a portion of the spline) or part of the way around the spline 66 and are typically a separate element from the spline 66 A and placed on the spline 66 A.
  • Printed electrodes can be formed by, for example, depositing material onto the spline 66 A by additive manufacturing, a printing process, or some other similar method. The printed electrodes can also be located on a substrate that is then placed on the spline 66 A.
  • Each of the printed electrodes can be similar to each of the ring electrodes and cover an entire circumference of a portion of the spline 66 A or the printed electrode scan cover only a portion of a circumference at the portion of the spline 66 A.
  • a mixture of interactive elements types can be included on a single spline (e.g., any combination of ring electrodes and printed electrodes discussed herein can be used).
  • Each of the plurality of interactive elements can be any suitable size (i.e., longitudinal length, width, etc.).
  • An embodiment can have a longitudinal length (length of the sensor as measured along a longitudinal axis of a spline) of each of the plurality of interactive elements of approximately 1 mm.
  • Another embodiment can have a mixture of interactive elements with different longitudinal length (e.g., some interactive elements 1 mm long, other interactive elements approximately 1.5 mm long, still other interactive elements approximately 2 mm long, etc.).
  • the longitudinal length of each interactive elements can range between approximately 0.1 mm and 5.0 mm.
  • the basket 62 A can have a first shape and a second shape.
  • the first shape can be an undeployed configuration that allows the basket 62 A to fit inside a catheter or other elongate medical device for delivery to a location in a body.
  • the second shape shown in FIG. 3 A , can be a deployed configuration.
  • the deployment/undeployment of the basket 62 A can be controlled by pull wires or other similar mechanisms and/or through the use of materials that are self-erecting (e.g., Nitinol).
  • the shape of the basket 62 A can vary depending on the configuration achieved using the pull wires or other deployment mechanism.
  • the deflection control member 68 can move longitudinally, which can cause the basket 62 A to change shape.
  • the deflection control member 68 can be used to support a particular shape/configuration of the basket 62 A. Additional discussion about the deflection control mechanism are found below, including with respect to FIGS. 8 A-C .
  • the deflection control member 68 A can have a deflection control member distal end 72 that can be coupled with a portion of the basket 62 A (e.g., the distal hub 64 A) and a deflection control member proximal end (not shown in FIG. 3 A ) that can be coupled with a control mechanism (e.g., a portion of the handle 24 of FIG. 1 and/or handle 14 A of FIG. 2 ).
  • the deflection control member 68 A can be a rigid element (e.g., a tube), a semi-rigid element (e.g., a flexible tube) or a flexible element (e.g., a polymer and/or metal cable, string cord or similar element).
  • the deflection control member 68 A can include a lumen suitable for irrigation fluids (not shown).
  • the deflection control member 68 A can also include one or more irrigation ports (not shown), including ports similar to those found in U.S. application 2017/0065227, which is incorporated herein by reference in its entirety.
  • FIG. 3 B is an isometric view of a catheter including a basket comprising multiple splines where one or more of the splines includes one or more interactive elements located at a proximal portion of the respective spline, in accordance with embodiments of the present disclosure.
  • An elongate medical device 60 B i.e., a catheter 60 B
  • the basket 62 B can also include a deflection control member (not shown) and the plurality of splines 66 B can couple with a distal hub 64 B.
  • the one or more interactive elements 70 prox located at a proximal portion of the one or more splines 66 B and can facilitate contact with tissue (e.g., a heart wall such as the septum between the right atrium/left atrium at the fossa crossing) proximal the proximal end of the basket 62 B for therapy (e.g., ablation).
  • tissue e.g., a heart wall such as the septum between the right atrium/left atrium at the fossa crossing
  • therapy e.g., ablation
  • the exemplary interactive elements 70 B shown in FIG. 3 B can include printed interactive elements, although any suitable type of electrode can be used as discussed herein.
  • FIG. 4 is a side view of a distal portion of a catheter including a basket comprising multiple splines and two magnetic sensors positioned in a distal location of the basket, in accordance with embodiments of the present disclosure.
  • a distal portion of a catheter 60 C can include a distal hub 64 C, splines 66 C, and a deflection control member 68 C, where the distal hub further comprises two magnetic sensors 74 .
  • the embodiment shown in FIG. 4 includes two magnetic sensors 74 (one magnetic sensor is hidden from view in FIG. 4 ) in a sensor tube 76 that is connected to the distal hub 64 C.
  • the magnetic sensors 74 can have a wire pair 78 (e.g., a twisted wire pair) connected to a controller (e.g., ECU 42 of FIG. 1 ).
  • the magnetic sensors 72 can allow the catheter 60 C to be tracked in a mapping system (e.g., the magnetic-field-based positioning system 38 of FIG. 1 ).
  • position data from the catheter can be obtained using a gMPS system, commercially available from Mediguide Ltd., and generally shown and described in U.S. Pat. No. 7,386,339 entitled “Medical Imaging and Navigation System,” which is incorporated herein by reference in its entirety.
  • the deflection control member 68 C can pass through the sensor tube 76 and couple with the distal hub 64 C as shown in FIG. 4 . In another embodiment (not shown), the deflection control member 68 could couple with the distal hub 64 C without passing through the sensor tube 76 .
  • the deflection control member 68 C can be a rigid element (e.g., a tube), a semi-rigid element (e.g., a flexible tube) or a flexible element (e.g., a polymer and/or metal string or cord). Additional discussion of deflection control member movements and functions can be found below (see, e.g., FIGS. 8 A-C and related discussion).
  • the distal hub 64 C can include a plurality of spline openings 80 .
  • Each of the splines 66 C can couple with distal hub 64 C through one of the plurality of distal hub spline openings 80 .
  • the embodiment shown in FIG. 4 shows only two splines 66 C connected to the distal hub 64 C.
  • Some of the plurality of distal hub spline openings 80 in FIG. 4 are open as the corresponding splines 66 C are omitted.
  • the distal hub 64 C can be any suitable material (e.g., polymer, metal).
  • the distal hub 64 C can have a diameter sized to fit within an elongate medical device (e.g., a sheath or an introducer).
  • the basket 62 C can be deployed from an elongate device (e.g., the basket 62 C (only a portion of which is shown in FIG. 4 ; see, for example, baskets 62 A and 62 B in FIGS. 2 A-B ) is pushed forward out of the elongate device and/or the elongate device is pulled back with respect to the basket 62 C).
  • an elongate device e.g., the basket 62 C (only a portion of which is shown in FIG. 4 ; see, for example, baskets 62 A and 62 B in FIGS. 2 A-B ) is pushed forward out of the elongate device and/or the elongate device is pulled back with respect to the basket 62 C).
  • the plurality of distal hub spline openings 80 can be sized to accommodate a variety of spline sizes and/or to allow for the spline 66 C to move (e.g., pivot, slide, etc.) within the distal hub spline opening 80 .
  • Each of the splines 66 C may move within the spline opening 80 , for example, during deployment of a basket (e.g., basket 62 A, 62 B of FIGS. 3 A-B ) and/or during adjustment of the basket shape (e.g., using the deflection control member as described herein) or other suitable times during usage of the catheter 60 C.
  • FIG. 5 A is a side view of a distal end portion of a distal portion of a catheter including a basket comprising a plurality of splines including two magnetic sensors positioned at a proximal location of the basket, in accordance with embodiments of the present disclosure.
  • a catheter 60 D can include a distal hub 64 D and a proximal hub 82 , a plurality of splines 66 D, and a deflection control member 68 D, where the proximal hub 82 further comprises a magnetic sensor 74 B.
  • the embodiment shown in FIG. 5 A includes two magnetic sensors 74 B (one magnetic sensor is hidden from view in FIG.
  • a sensor tube that is, in this embodiment, integrated with the proximal hub 82 .
  • the sensor tube and the hub can be combined separate elements (e.g., see FIG. 4 ).
  • the sensor tube and/or the hub can be part of a distal end of elongate shaft (e.g., a catheter).
  • Each of the plurality of splines 66 D can have a spline distal end 84 and a spline proximal end 86 .
  • the spline distal end 84 can couple with the distal hub 64 D and the spline proximal end 86 can couple with the proximal hub 82 .
  • each of the spline distal ends 84 can couple with distal hub 64 D through one of the plurality of distal hub spline openings 80 B.
  • each of the plurality of splines 66 D can include, at the spline proximal end 86 , a spline straight portion 88 .
  • the spline straight portion 88 can be aligned with a longitudinal axis, represented by the line A-A, of the proximal hub 82 .
  • the proximal hub can include openings (e.g., similar to the distal hub 64 C in FIG. 4 ) or other suitable configurations that allow the distal hub to couple with the spline proximal end.
  • the proximal hub 82 can include a central lumen (i.e., an opening; not visible in FIG. 5 A ) and some embodiments of the proximal hub 82 can include a coupler (not visible in FIG. 5 A ). Additional information about the central lumen and/or the coupler can be found in FIGS. 6 A-C and the related discussion.
  • the deflection control member 68 D can pass through the central lumen of the proximal hub 82 .
  • Other elements (not shown in FIG. 5 A ) can also be located in the central lumen including, for example, control wires, electrical wires, fluid lumens, etc.).
  • the magnetic sensors 74 B can be connected to a controller (e.g., ECU 42 of FIG. 1 ) and/or other electrical device by a pair of wires 78 B (e.g., a twisted wire pair).
  • the magnetic sensors 74 B can allow the catheter to be tracked in a mapping system.
  • FIG. 5 B is a side view of the distal end portion of the catheter of FIG. 5 A including the two magnetic sensors positioned at the proximal location of the basket, in accordance with embodiments of the present disclosure. As described above, FIG. 5 B includes two magnetic sensors 74 B in a sensor tube that is integrated with the proximal hub 82 .
  • the proximal hub 82 can be located inside a distal end of a catheter shaft or outside the distal end of a catheter shaft and coupled with the distal end of the catheter shaft (not shown).
  • the proximal hub can include integrated sensor tubes 76 B for the magnetic sensors 74 B (not shown).
  • FIGS. 6 A-C show a coupler, in accordance with embodiments of the present disclosure.
  • FIG. 6 A is a cross-sectional view of a proximal end of the coupler.
  • FIG. 6 B is a side view of the coupler.
  • FIG. 6 C is a cross-sectional view of the distal end of the coupler.
  • a coupler 90 can comprise a body 92 , a proximal end 94 , and a distal end 96 .
  • the distal end 96 can include a plurality of coupling locations 98 (i.e., grooves, slots, etc.) configured to couple with a proximal end of a spline (e.g., splines 66 D of FIG. 5 B ).
  • the proximal hub 82 can include the coupler 90 .
  • a deflection control member e.g., deflection control member 68 D
  • other items e.g., control wires, lumens, electrical wires, etc.
  • the proximal end can be coupled with a shaft or other elongate medical device (e.g., shaft 28 of FIG. 1 and/or elongated catheter body 19 of FIG. 2 ).
  • FIG. 7 is a cross-sectional view of a catheter including a plurality of lumens for use with a catheter, in accordance with embodiments of the present disclosure.
  • the catheter 100 can comprise a first lumen 102 and two second lumens 104 .
  • the first lumen can be shaped like a peanut (e.g., two circular cross-sections connected).
  • the first lumen can contain one or more tubes (not shown) to contain (i.e. containment tubes) or house various elements such as wires for sensors, interactive elements, or similar devices and/or fluid (e.g., saline) to connect from a distal location on the catheter 100 to a proximal location.
  • FIG. 8 A is a side view of a distal end portion of a catheter including a basket comprising multiple splines and a deflection control member with the basket in a first configuration, in accordance with embodiments of the present disclosure.
  • the catheter 60 E can comprise a basket 62 E that is located at a distal end portion of the catheter 60 E.
  • the basket 62 E can comprise a distal hub 64 E and a plurality of splines 66 E and a [deflection control member] 68 E.
  • each of the plurality of splines 66 E can include a plurality of interactive elements (not shown in FIG. 8 A , e.g., the interactive elements 70 A in FIG. 3 A , where 70 x can represent individual interactive elements in the plurality of interactive elements 70 1 , 70 2 , 70 3 , . . . etc.).
  • spacing of the plurality of interactive elements 70 A can be equal or unequal.
  • the plurality of interactive elements 70 A can all have an equal distance between each of the plurality of interactive elements 70 A (e.g., 1 mm between each electrode).
  • the spacing can vary between the plurality of interactive elements 70 (e.g., 1 mm between some of the plurality of interactive elements 70 A and 2 mm between others of the plurality of interactive elements 70 ).
  • spacing between each of the plurality of interactive elements 70 A can vary along each spline 66 E and/or differ from spline to spline.
  • distribution of the plurality of interactive elements 70 A can also vary between embodiments.
  • the basket 62 E can have a first deployed shape, a second deployed shape, and a third deployed shape.
  • the basket 62 E can have a diameter D 1 (i.e., width) for the first deployed shape, a diameter D 2 for the second deployed shape (see FIG. 8 B ) and a diameter D 3 for the third deployed shape (see FIG. 8 C ) where D 1 is greater than D 2 and D 2 is greater than D 1 .
  • the basket 62 E can also have an undeployed shape (i.e., undeployed configuration; not shown) that allows the basket 62 E to fit inside a catheter or other elongate medical device for delivery to a location in a body. A diameter of the undeployed shape of the basket is less than D 3 .
  • the second deployed shape and the third deployed shapes are shown in FIGS. 8 B and 8 C ; see related discussion).
  • the deployment/undeployment of the basket 62 E can be controlled by pull wires or other similar mechanisms and/or through the use of materials that are self-erecting (e.g., Nitinol).
  • the shape of the basket 62 E can vary depending on the configuration achieved using any one of the pull wires, the deflection control member 68 E, and/or other deployment mechanisms.
  • the deflection control member 68 E can have a deflection control member distal end that can be coupled with a portion of the basket 62 E (e.g., the distal hub 64 E) and a deflection control member proximal end (not shown in FIG. 8 A ) that can be coupled with a control mechanism (e.g., a portion of the handle 24 of FIG. 1 and/or handle 14 A of FIG. 2 ).
  • the deflection control member 68 E can be a rigid element (e.g., a tube), a semi-rigid element (e.g., a flexible tube) or a flexible element (e.g., a polymer and/or metal cable, string cord or similar element).
  • the deflection control member 68 E can move longitudinally, which can cause the basket 62 E to change shape.
  • the deflection control member 68 E can be used to support a desired shape/configuration of the basket 62 E.
  • the deflection control member 68 E can provide support (i.e., rigidity, stiffness) to the basket 62 E to maintain a specific deployed shape.
  • the deflection control member 68 E can provide support to the basket 62 E to maintain the width D 1 (with respect to a longitudinal axis of the catheter 60 E) of the first deployed shape.
  • the basket 62 E can have a “softer” structure (i.e., reduced rigidity, more flexible) allowing the basket 62 E to float with the rigidity of the basket 62 E controlled by the stiffness of the splines 66 E only. Adjustment of the deflection control member 68 E could allow additional deflection of the basket 62 E as the splines 66 E and/or distal hub 64 E contact tissue (e.g., the distal hub 64 E could move more, allowing the spline distal ends and the spline proximal ends to have a greater range of motion, depending on the force exerted on the catheter 60 E and the material properties of the splines/basket).
  • the basket 62 E can be pushed to contact tissue (e.g., cardiac tissue 16 in FIG. 1 ) and the splines 66 E of the basket 62 E can allow the basket to be larger than the contacted tissue (e.g., larger than a pulmonary vein).
  • the splines 66 E can also allow the basket 62 E to be symmetrical or non-symmetrical depending on the configuration of the tissue contacted.
  • the deflection control member 68 E can be engaged at any time during use to change the stiffness/rigidity (i.e., stiffness profile) of the basket (and also change the shape, along with push/pull wires and other control mechanisms) as desired by the user.
  • the basket 62 E when the deflection control member 68 E is not engaged/used the basket 62 E can have a first stiffness profile and the basket 62 E can have a second stiffness profile when the deflection control member 68 E is fully engaged and providing maximum support to the basket 62 E. Additional variations in support provided by the deflection control member can allow for additional stiffness profiles of the basket (e.g., a third stiffness profile, a fourth stiffness profile, etc.).
  • the diameter of the basket 62 E can be increased for optimal surface contact between the splines 66 E and the tissue proximate the splines 66 E (e.g., optimal contact between interactive elements on the splines and the tissue).
  • FIG. 8 B is a side view of the catheter of FIG. 8 A in a second configuration, in accordance with embodiments of the present disclosure.
  • the diameter D 2 of the second deployed shape of the basket 62 E shown in FIG. 6 B can be larger than the diameter D 1 for the first deployed shape (shown in FIG. 8 A ), and smaller than the diameter D 3 for the third deployed shape (see FIG. 8 C ).
  • the second deployed shape can be achieved by using any combination of one or more of the deflection control member 68 E, the structure of the splines 66 E (e.g., provided by shape memory materials such as Nitinol), and push/pull wires or other control mechanisms.
  • the catheter With the deflection control member 68 E released (e.g., loose; not being used to support and/or provide control of the shape of the basket 62 E), the catheter can be pushed causing the basket 62 E to contact tissue.
  • the resistance provided by the tissue contact can allow the basket 62 E to change shapes (e.g., deflect larger than the current size (e.g., see FIG. 8 A ).
  • the expanded size of the basket 62 E can facilitate some potential apposition opportunities with tissue, and provide an element of safety regarding damage to tissue.
  • the catheter With the deflection control member 68 E engaged (e.g., being used to support and/or provide control of the shape of the basket 62 E), the catheter can be pushed into tissue with a firmer/stiffer configuration to engage tissue as desired.
  • FIG. 8 C is a side view of the catheter of FIG. 8 A in a third configuration, in accordance with embodiments of the present disclosure.
  • the diameter D 3 of the third deployed shape of the basket 62 E shown in FIG. 8 C can be smaller than the diameter D 1 for the first deployed shape (shown in FIG. 8 A ), and smaller than the diameter D 2 for the second deployed shape (see FIG. 8 B ).
  • the third deployed shape can be achieved by using any combination of one or more of the deflection control member 68 E, the structure of the splines 66 E (e.g., provided by shape memory materials such as Nitinol), and push/pull wires or other control mechanisms.
  • the diameter and/or the stiffness of the basket 62 E can be changed to assist in positioning relative to heart features and then the diameter and/or stiffness can be changed again to optimize contact between portions of the basket 62 E and tissue.
  • FIG. 9 A is a partial cross-sectional view of a distal end portion of a catheter with a basket and a deflection control member, in accordance with embodiments of the present disclosure.
  • a catheter 60 F can include a plurality of splines 66 F in a basket 62 F. A distal end of the splines 66 F can couple with a distal hub 64 F.
  • a distal end of a deflection control member 72 F can couple with the distal hub 64 F and a proximal end of the deflection control member 72 F (not shown in FIG. 9 A ) can be located in a portion of a shaft (e.g., shaft 28 of FIG. 1 and/or elongated catheter body 19 of FIG. 2 ) and couple with a handle (e.g., handle 24 of FIG. 1 , and/or handle 14 A of FIG. 2 ) or some other proximal control mechanism.
  • a shaft e.g., shaft 28 of FIG. 1 and/or
  • the deflection control member 72 F can comprise any suitable material including a polyimide (PI) tube, PI tube w/braid reinforcement, PI tube w/stainless steel wire down interior diameter of PI tube, etc.
  • any portion (e.g., exterior surface of deflection control member 72 F, interior surface proximate a wire, etc.) of the deflection control member 72 F can include a coating to promote movement (reduction of friction, etc.).
  • the configuration of the basket 62 F shown in FIG. 9 A can be similar to the configuration shown in FIG. 8 B and discussed above. As discussed, the deflection control member 72 F can be engaged or released as desired to manipulate the amount of support/rigidity of the basket 62 F.
  • FIG. 9 B is a side view of a distal end portion of a catheter including a basket comprising multiple splines and a deflection control member, in accordance with embodiments of the present disclosure.
  • a catheter 60 G can include a plurality of splines 66 F in a basket 62 G.
  • a distal end of the splines 66 F can couple with a distal hub 64 G.
  • a distal end of a deflection control member 72 G can couple with the distal hub 64 G and a proximal end of the deflection control member 72 F (not shown in FIG. 9 B ) can be located in a portion of a shaft (e.g., shaft 28 of FIG.
  • the basket 62 G can also include a magnetic sensor 74 G coupled with the distal hub 64 G.
  • the magnetic sensor 74 G can include a wire pair 78 G.
  • the deflection control member 72 G can be used to form the third deployed shape of the basket 62 G shown in FIG. 9 B (similar to the configuration of basket 62 E in FIG. 8 B and discussed above.
  • the shape of basket 62 G can be achieved by using any combination of one or more of the deflection control member 68 G, the structure of the splines 66 G (e.g., provided by shape memory materials such as Nitinol), and push/pull wires or other control mechanisms.
  • the diameter and/or the stiffness of the basket 62 G can be changed to assist in positioning relative to heart features and then the diameter and/or stiffness can be changed again to optimize contact between portions of the basket 62 G and tissue.
  • FIGS. 10 A and 10 B are isometric views of a movement limiter for limiting and/or preventing longitudinal movement of a deflection control member, where FIG. 10 A shows the movement limiter in a first position and FIG. 10 B shows the clamping mechanism (i.e., a clamp) in a second position, in accordance with embodiments of the present disclosure.
  • a movement limiter (i.e., a clamping mechanism) 110 can comprise a first clamping element 112 and a second clamping element 114 .
  • the first clamping element 112 and the second clamping element 114 can be proximate a deflection control member 72 H.
  • the first clamping element 112 and the second clamping element can have a first position (i.e., a neutral position, an open position, an unlocked position, etc.) where the deflection control element 72 H is free to move through the clamping mechanism 110 .
  • the deflection control member 72 H is either not in contact with one of the first clamping element 112 and the second clamping element 114 or both of the first clamping element 112 and the second clamping element 114 .
  • This open position can be achieved by movement of either the first clamping element 112 or the second clamping element 114 or movement of both the first clamping element 112 and the second clamping element 114 (i.e., one or more portions of the clamping element 114 is movable).
  • FIG. 10 B shows the clamping mechanism 110 in a second position (i.e., a closed position, a locked position, etc.) where the deflection control element 72 H is not free to move through the clamping mechanism 110 .
  • the clamping mechanism can use friction and/or physical deformation to prevent movement of the deflection control member 72 H. Portions of the first clamping element 112 and the second clamping element 114 can be treated to increase friction between the deflection control member 72 H and the first clamping element 112 and the second clamping element 114 (e.g., coatings, ridges, texture, etc.).
  • the closed position can include, “fully” closed and “partially” closed where fully closed prevents any longitudinal movement of the deflection control member and partially closed limits the longitudinal movement (e.g., some slippage can occur, depending on the clamping forces involved).
  • clamping mechanism 110 One embodiment of how the clamping mechanism 110 could be used is as follows:
  • a user could generate linear or rotational motion using a handle (e.g., handle 24 in FIG. 1 ) to create forward (i.e., longitudinal) motion of the deflection member (e.g., deflection member 72 H).
  • the forward motion of the deflection member would occur when the clamping mechanism is closed (i.e., clamped shut, in contact with the deflection member; see FIG. 10 B ) around the deflection member. If the clamping mechanism is open (e.g., FIG. 10 A ) the deflection member would be free to move back and forth within the open clamping mechanism.
  • the clamping mechanism Upon actuating a lever (e.g., moving and/or rotating a lever on the handle) the clamping mechanism could close and allow the movement of the deflection member to move and change the profile (i.e., shape) of the basket as described herein (e.g., elongate the basket with a smaller diameter as shown in FIG. 8 C , or shorten the length of the basket and increase the diameter as shown in FIG. 8 A ). Releasing the lever would allow the basket to return to nominal size (e.g., FIG. 8 B ) and release the deflection member for free movement.
  • a lever e.g., moving and/or rotating a lever on the handle
  • the clamping mechanism could close and allow the movement of the deflection member to move and change the profile (i.e., shape) of the basket as described herein (e.g., elongate the basket with a smaller diameter as shown in FIG. 8 C , or shorten the length of the basket and increase the diameter as shown in FIG
  • FIG. 11 A is a partial cross-sectional view of a portion of a handle for controlling an elongated medical device including a selective movement limiter for preventing longitudinal movement of the elongated medical device, in accordance with embodiments of the present disclosure.
  • a handle portion 120 can include a selective movement limiter (i.e., a clamping mechanism) 122 that includes a first clamping element 124 and a second clamping element 126 , a thumb lever 128 , and a thumb lever engagement post 130 coupled with the clamping mechanism 122 and the thumb lever 128 .
  • a selective movement limiter i.e., a clamping mechanism
  • a user can move the thumb lever 128 (e.g., slide the thumb lever 128 to the left (towards A 1 ) in a direction aligned with a longitudinal axis represented by the line A 1 -A 2 ) that, in turn, moves the thumb lever engagement post 130 in the same direction, which can cause the clamping mechanism 122 to move (e.g., as indicated by arrow A).
  • This movement of the clamping mechanism 122 can cause the first clamping element 124 and the second clamping element 126 to engage with the deflection control member 72 I and prevent and/or limit movement of the deflection control member 72 I along a longitudinal axis aligned with the line A 1 -A 2 .
  • FIG. 11 B is an isometric view of the clamping mechanism of FIG. 11 A for limiting and/or preventing longitudinal movement of the elongated medical device, in accordance with embodiments of the present disclosure.
  • the clamping mechanism 122 can include a first clamping element 124 and a second clamping element 126 . Movement of the clamping mechanism along the longitudinal axis aligned with the line A 1 -A 2 can cause the first clamping element 124 and the second clamping element 126 to engage with the deflection control member 72 I and prevent and/or limit movement of the deflection control member 72 I. Movement of the first clamping element can occur as indicated by the arrow A shown in FIG. 11 B .
  • some embodiments of the clamping mechanism can include movement of both the first clamping element 124 and the second clamping element 126 (now shown in FIG. 11 B ; see FIG. 11 B and related discussion).
  • FIG. 11 C is an isometric view of a portion of the clamping mechanism of FIGS. 11 A-B for preventing longitudinal movement of the elongated medical device, in accordance with embodiments of the present disclosure.
  • FIG. 12 A is a side view of a portion of the a catheter including a basket comprising multiple splines with a first spline shape, in accordance with embodiments of the present disclosure.
  • a catheter 60 J can comprise a distal hub 64 J and a plurality of splines 66 J (two splines 66 J are shown; additional splines omitted from this view) as shown in FIG. 12 A .
  • Each of the plurality of splines 66 J can have a first spline shape as shown in FIG. 12 A , where the spline comprises one or more curved portions.
  • the curved portions can each have a radius that is the same (e.g., the side view of the two splines 66 J essentially form a circle) as shown in FIG. 12 A .
  • the shape of the splines shown in FIG. 12 A allows the distal hub 64 J to be the first portion of the catheter 60 J to contact tissue 140 A (e.g., endocardium tissue) as the catheter 60 J is moved distally.
  • tissue 140 A e.g., endocardium tissue
  • the curvature of the curved portions of the plurality of splines 66 J can allow interactive elements (not shown in FIG. 12 A ; described herein such as interactive elements 70 A, 70 B in FIGS. 3 A-B ) on the splines 66 J to have an area of interactive element coverage 142 (e.g., 142 A, 142 B, 142 C).
  • the area of interactive element coverage 142 can be larger or smaller than the area shown in FIG. 12 A depending on the number and/or placement of interactive elements on the splines.
  • the curvature of the plurality of splines 66 J. combined with the number and/or placement of interactive elements, does not allow much, if any, contact between the endocardium tissue 140 A and a distal portion of the area of electrode coverage 142 A.
  • Contact between the endocardium tissue 140 A and the interactive elements can be increased by, for example, changing the shape of the splines (e.g., adjusting a size of the basket of the catheter using push/pull wires and/or a deflection control member-see FIGS. 8 A-C and related discussion as an example) or by increasing force in the distal direction. Additional distal force on the catheter may cause the tissue to deform and increase contact with the area of electrode coverage 142 A. However, the excessive additional distal force can also cause tissue damage due to the distal hub 64 J.
  • the curvature of the plurality of splines 66 J shown in FIG. 12 A does not allow much, if any, contact with the endocardium tissue 140 A and a proximal portion of the area of electrode coverage 142 C.
  • changing the shape of the splines and/or using additional force could increase contact between proximal interactive elements (not shown in FIG. 12 A , see, e.g., electrode 70 prox in FIG. 3 B ). and endocardium tissue 140 B.
  • FIG. 13 B is a side view of a portion of a catheter including a basket comprising multiple splines with a second spline shape for increased contact between proximal portions of the spline and tissue, in accordance with embodiments of the present disclosure.
  • a catheter 60 K can comprise a distal hub 64 K and a plurality of splines 66 K (two splines 66 K are shown; additional splines omitted from this view) as shown in FIG. 12 B .
  • Each of the plurality of splines 66 K can have a first spline shape as shown in FIG. 12 B , where the spline comprises one or more curved portions.
  • the curved portions can have an different radii (e.g., the side view of the two splines 66 K essentially form a circle), especially at a distal portion of the splines (e.g., proximate the hub 64 K) and a proximal portion of the splines.
  • the multiple radii for the curve portions can allow a portion of the spline, and therefore a portion of the interactive elements on the spline, to contact tissue first.
  • interactive elements on the catheter 60 K can contact tissue 140 B (e.g., endocardium tissue) at an area of electrode coverage 142 C at a proximal portion of the splines can contact the tissue 140 B.
  • changing the shape of the catheter e.g., adjusting a size of the basket of the catheter using push/pull wires and/or a deflection control member-see FIGS. 8 A-C and related discussion as an example
  • changing the shape of the catheter can allow contact between a higher number of interactive elements and tissue 140 B.
  • joinder references are to be construed broadly and can include intermediate members between a connection of elements and relative movement between elements and can also include elements that are part of a mixture or similar configuration. As such, joinder references do not necessarily infer that two elements are directly connected and in fixed relation to each other. It is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative only and not limiting. Changes in detail or structure can be made without departing from the spirit of the disclosure as defined in the appended claims.
  • proximal and distal may be used throughout the specification with reference to a clinician manipulating one end of an instrument used to treat a patient.
  • proximal refers to the portion of the instrument closest to the clinician and the term “distal” refers to the portion located furthest from the clinician.
  • distal refers to the portion located furthest from the clinician.
  • spatial terms such as “vertical,” “horizontal,” “up,” and “down” may be used herein with respect to the illustrated embodiments.
  • surgical instruments may be used in many orientations and positions, and these terms are not intended to be limiting and absolute.

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US20230225789A1 (en) * 2022-01-20 2023-07-20 Biosense Webster (Israel) Ltd. Systems and methods for linear spines and spine retention hub for improved tissue contact and current delivery
WO2023196138A1 (fr) 2022-04-08 2023-10-12 St. Jude Medical, Cardiology Division, Inc. Extrémité distale de cathéter déflectable

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